Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters

Obesity Clinical Trial

— BLS-Sterno  

Official title:

Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828788
• Other study ID #: CHU-0151
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2013
• Est. completion date: January 19, 2015

Study information

• Verified date: July 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of coughing, deep breathing, and early mobilisation. It may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.

Description:

Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 19, 2015
• Est. primary completion date: January 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Scheduled cardiac surgery (aortic or mitral valve replacement, or coronary bypass surgery) with sternotomy.

• Patients will be at risk of noncardiac postoperative complications, i.e. age over 75, BMI over 30, pulmonary disease, or active smoking habit

Exclusion Criteria:

• surgery in emergency

• thoracotomy

• cardiac graft

• redo

• aortic dissection

• age over 85

• pregnancy

• patient's refusal

• minor or adult under legal protection

• psychiatric ongoing disease

• addiction to opiates

• ongoing opiate treatment

• inability to use a PCA device

• respiratory insufficiency (Vital capacity or maximal expired volume per sec. < 50% of the expected value, or mean PAP > 50 mmHg)

• cardiac failure or EF < 40% or intra-aortic balloon use

• pulmonary hypertension over 50 mmHg

• severe renal insufficiency

• history of allergy or intolerance to: morphine, acetaminophen, ropivacaine.

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Elderly Patients
• Obesity
• Scheduled Cardiac Surgery
• Sternotomy

Intervention

Drug:
• Ropivacaine

• placebo

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The deadline for obtaining all criteria consistent with an output of postoperative intensive care	The criteria will be considered by an independent adjudication committee unaware of the treatment given, according to a predefined checklist, whatever the actual delay for discharge. The checklist was built with the help of published recommendations [Camp et al. J Card Surg 2009; 24:414].	72 hours
Secondary	Surgery time		24 hours
Secondary	Quantity of sufentanil administered		72 hours
Secondary	Total morphine consumption		72 hours